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Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking CessationA Randomized Clinical Trial

Educational Objective
To learn about the use of electronic cigarettes (e-cigarettes) for smoking cessation.
1 Credit CME
Key Points

Question  What is the effect of e-cigarettes, added to individual counseling, on smoking cessation?

Findings  In this randomized clinical trial that was terminated early after enrolling 376 of a planned 486 participants, individuals randomized to nicotine e-cigarettes plus counseling, compared with counseling alone, had significantly greater 7-day point prevalence abstinence at 12 weeks (21.9% vs 9.1%, respectively), although the difference was no longer statistically significant at 24 weeks.

Meaning  Interpretation is limited by early trial termination, and further research is needed regarding long-term efficacy of e-cigarettes for smoking cessation.

Abstract

Importance  Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial.

Objective  To evaluate e-cigarettes with individual counseling for smoking cessation.

Design, Setting, and Participants  A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported.

Interventions  Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling.

Main Outcomes and Measures  The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence.

Results  Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, –1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, –0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).

Conclusions and Relevance  Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.

Trial Registration  ClinicalTrials.gov Identifier: NCT02417467

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Corresponding Author: Mark J. Eisenberg, MD, MPH, Divisions of Cardiology and Clinical Epidemiology, Jewish General Hospital/McGill University, 3755 Côte Sainte-Catherine Rd, Ste H-421.1, Montréal, Québec, Canada H3T 1E2 (mark.eisenberg@mcgill.ca).

Accepted for Publication: September 5, 2020.

Author Contributions: Drs Eisenberg and Filion had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors agreed to be accountable for all aspects of the work, and ensure the accuracy and integrity of any part of the work.

Concept and design: Eisenberg, Windle, Filion.

Acquisition, analysis, or interpretation of data: Eisenberg, Hébert-Losier, Windle, Greenspoon, Brandys, Fülöp, Nguyen, Elkouri, Montigny, Wilderman, Bertrand, Bostwick, Abrahamson, Lacasse, Pakhale, Cabaussel, Filion.

Drafting of the manuscript: Eisenberg, Hébert-Losier, Windle, Filion.

Critical revision of the manuscript for important intellectual content: Eisenberg, Windle, Greenspoon, Brandys, Fülöp, Nguyen, Elkouri, Montigny, Wilderman, Bertrand, Bostwick, Abrahamson, Lacasse, Pakhale, Cabaussel, Filion.

Statistical analysis: Cabaussel, Filion.

Obtained funding: Eisenberg, Windle, Filion.

Administrative, technical, or material support: Hébert-Losier, Windle, Greenspoon, Brandys, Fülöp, Abrahamson, Lacasse.

Supervision: Eisenberg, Hébert-Losier, Greenspoon, Brandys, Fülöp, Nguyen, Elkouri, Montigny, Wilderman, Bertrand, Bostwick, Lacasse, Pakhale.

Conflict of Interest Disclosures: Dr Eisenberg reported receiving educational grants from Pfizer Inc for providing continuing medical education in cardiology. Dr Wilderman reported receiving financial compensation from Pfizer Inc for his involvement in a smoking cessation study using varenicline. Dr Filion reported receiving salary support from the Fonds de Recherche du Quebec, a William Dawson Scholar award from McGill University, and personal fees from Institut National D’excellence en Santé et Services Sociaux. No other disclosures were reported.

Funding/Support: This trial was funded by the Canadian Institutes of Health Research (CIHR; funding reference No. 133727 and 155969). Both nicotine e-cigarettes and nonnicotine e-cigarettes were purchased from NJOY Inc (Scottsdale, Arizona).

Role of the Funder/Sponsor: The CIHR and NJOY Inc had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: The E3 Investigators were as follows: Nonauthor site investigators who contributed to data collection: Portsmounth Medical Clinic, Kingston, Ontario, Canada, Gregory Paul Baran, MD; Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada, Gabor Gyenes, MD, PhD; Toronto General Hospital, Toronto, Ontario, Canada, Vivek Rao, MD, PhD; and Montréal General Hospital, Montréal, Québec, Canada, Thao Huynh, MD, PhD. Data and safety monitoring board members who provided independent oversight concerning the safety of study participants and the scientific integrity of the trial: University of Calgary, Calgary, Alberta, Canada, Peter Faris, PhD (chair); University of Alberta, Edmonton, Alberta, Canada, Finlay McAlister, MD; and Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, Andrea Gershon, MD. End points evaluation committee members who provided independent adjudication of serious adverse events: Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, Ontario, Canada, Patrick R. Lawler, MD; Center for Pulmonary Vascular Disease, Azrieli Heart Center, Division of Cardiology, Jewish General Hospital, Montréal, Québec, Canada, Ali O. Abualsaud, MD; and Division of Nephrology, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada, Ratna Samanta, MD.

Additional Contributions: We thank the individuals who participated in the trial, and the study personnel involved in enrollment and follow-up. We also thank Natalie Zacchia, MPH, and Shauna McGee, MSc, for their assistance with trial initiation and coordination, as well as Kristina Wade, BSc, Samantha Lancione, BSc, and Sophie Sun, all from the Lady Davis Institute, Montréal, Québec, Canada, for assistance in maintaining the trial database. We thank Louise Pilote, MD, MPH, PhD (McGill University Health Centre, Montréal, Québec, Canada), for helpful insights during the conduct of the trial and editorial assistance with the manuscript. Dr Pilote, Ms Wade, Ms Lancione, and Ms Sun did not receive compensation for their role in this trial; each of the other named persons did receive compensation for their role in this trial.

Data Sharing Statement: See Supplement 3.

References
1.
National Center for Chronic Disease Prevention.  The Health Consequences of Smoking: 50 Years of Progress: A Report of the Surgeon General. Centers for Disease Control and Prevention; 2014.
2.
Siahpush  M , Shaikh  RA , McCarthy  M , Sikora Kessler  A , Tibbits  M , Singh  GK .  Association between duration of use of pharmacotherapy and smoking cessation: findings from a national survey.   BMJ Open. 2015;5(1):e006229. doi:10.1136/bmjopen-2014-006229PubMedGoogle Scholar
3.
Hajek  P , Phillips-Waller  A , Przulj  D ,  et al.  A randomized trial of e-cigarettes versus nicotine-replacement therapy.   N Engl J Med. 2019;380(7):629-637. doi:10.1056/NEJMoa1808779 PubMedGoogle ScholarCrossref
4.
Bullen  C , Howe  C , Laugesen  M ,  et al.  Electronic cigarettes for smoking cessation: a randomised controlled trial.   Lancet. 2013;382(9905):1629-1637. doi:10.1016/S0140-6736(13)61842-5 PubMedGoogle ScholarCrossref
5.
Caponnetto  P , Campagna  D , Cibella  F ,  et al.  EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study.   PLoS One. 2013;8(6):e66317. doi:10.1371/journal.pone.0066317 PubMedGoogle Scholar
6.
Lee  S-H , Ahn  S-H , Cheong  Y-S .  Effect of electronic cigarettes on smoking reduction and cessation in Korean male smokers: a randomized controlled study.   J Am Board Fam Med. 2019;32(4):567-574. doi:10.3122/jabfm.2019.04.180384 PubMedGoogle ScholarCrossref
7.
Masiero  M , Lucchiari  C , Mazzocco  K ,  et al.  E-cigarettes may support smokers with high smoking-related risk awareness to stop smoking in the short run: preliminary results by randomized controlled trial.   Nicotine Tob Res. 2019;21(1):119-126. doi:10.1093/ntr/nty047 PubMedGoogle ScholarCrossref
8.
Walker  N , Parag  V , Verbiest  M , Laking  G , Laugesen  M , Bullen  C .  Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial.   Lancet Respir Med. 2020;8(1):54-64. doi:10.1016/S2213-2600(19)30269-3 PubMedGoogle ScholarCrossref
9.
Carpenter  MJ , Heckman  BW , Wahlquist  AE ,  et al.  A naturalistic, randomized pilot trial of e-cigarettes: uptake, exposure, and behavioral effects.   Cancer Epidemiol Biomarkers Prev. 2017;26(12):1795-1803. doi:10.1158/1055-9965.EPI-17-0460 PubMedGoogle ScholarCrossref
10.
Halpern  SD , Harhay  MO , Saulsgiver  K , Brophy  C , Troxel  AB , Volpp  KG .  A pragmatic trial of e-cigarettes, incentives, and drugs for smoking cessation.   N Engl J Med. 2018;378(24):2302-2310. doi:10.1056/NEJMsa1715757 PubMedGoogle ScholarCrossref
11.
Tseng  T-Y , Ostroff  JS , Campo  A ,  et al.  A randomized trial comparing the effect of nicotine versus placebo electronic cigarettes on smoking reduction among young adult smokers.   Nicotine Tob Res. 2016;18(10):1937-1943. doi:10.1093/ntr/ntw017 PubMedGoogle ScholarCrossref
12.
Hébert-Losier  A , Filion  KB , Windle  SB , Eisenberg  MJ .  A randomized controlled trial evaluating the efficacy of e-Cigarette use for smoking cessation in the general population: E3 trial design.   CJC Open. 2020;2(3):168-175. doi:10.1016/j.cjco.2020.03.006PubMedGoogle ScholarCrossref
13.
Hummel  K , Brown  J , Willemsen  MC , West  R , Kotz  D .  External validation of the Motivation To Stop Scale (MTSS): findings from the International Tobacco Control (ITC) Netherlands Survey.   Eur J Public Health. 2017;27(1):129-134.PubMedGoogle Scholar
14.
Heatherton  TF , Kozlowski  LT , Frecker  RC , Fagerström  KO .  The Fagerström Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire.   Br J Addict. 1991;86(9):1119-1127. doi:10.1111/j.1360-0443.1991.tb01879.x PubMedGoogle ScholarCrossref
15.
Glover  ED , Nilsson  F , Westin  A , Glover  PN , Laflin  MT , Persson  B .  Developmental history of the Glover-Nilsson Smoking Behavioral Questionnaire.   Am J Health Behav. 2005;29(5):443-455. doi:10.5993/AJHB.29.5.7 PubMedGoogle ScholarCrossref
16.
Beck  AT , Steer  RA , Brown  GK .  Beck Depression Inventory-II. Psychological Corporation; 1996;78:490-498.
17.
SRNT Subcommittee on Biochemical Verification.  Biochemical verification of tobacco use and cessation.   Nicotine Tob Res. 2002;4(2):149-159. doi:10.1080/14622200210123581 PubMedGoogle ScholarCrossref
18.
Eisenberg  MJ , Filion  KB , Yavin  D ,  et al.  Pharmacotherapies for smoking cessation: a meta-analysis of randomized controlled trials.   CMAJ. 2008;179(2):135-144. doi:10.1503/cmaj.070256 PubMedGoogle ScholarCrossref
19.
Begh  R , Lindson-Hawley  N , Aveyard  P .  Does reduced smoking if you can’t stop make any difference?   BMC Med. 2015;13:257. doi:10.1186/s12916-015-0505-2 PubMedGoogle ScholarCrossref
20.
Carpenter  MJ , Hughes  JR , Solomon  LJ , Callas  PW .  Both smoking reduction with nicotine replacement therapy and motivational advice increase future cessation among smokers unmotivated to quit.   J Consult Clin Psychol. 2004;72(3):371-381. doi:10.1037/0022-006X.72.3.371 PubMedGoogle ScholarCrossref
21.
Ellington  S , Salvatore  PP , Ko  J ,  et al; Lung Injury Response Epidemiology/Surveillance Task Force.  Update: product, substance-use, and demographic characteristics of hospitalized patients in a nationwide outbreak of e-cigarette, or vaping, product use-associated lung injury: United States, August 2019–January 2020.   MMWR Morb Mortal Wkly Rep. 2020;69(2):44-49. doi:10.15585/mmwr.mm6902e2 PubMedGoogle ScholarCrossref
22.
Blount  BC , Karwowski  MP , Shields  PG ,  et al; Lung Injury Response Laboratory Working Group.  Vitamin E acetate in bronchoalveolar-lavage fluid associated with EVALI.   N Engl J Med. 2020;382(8):697-705. doi:10.1056/NEJMoa1916433 PubMedGoogle ScholarCrossref
23.
Ghosh  A , Coakley  RC , Mascenik  T ,  et al.  Chronic e-cigarette exposure alters the human bronchial epithelial proteome.   Am J Respir Crit Care Med. 2018;198(1):67-76. doi:10.1164/rccm.201710-2033OC PubMedGoogle ScholarCrossref
24.
Ghosh  A , Coakley  RD , Ghio  AJ ,  et al.  Chronic e-cigarette use increases neutrophil elastase and matrix metalloprotease levels in the lung.   Am J Respir Crit Care Med. 2019;200(11):1392-1401. doi:10.1164/rccm.201903-0615OC PubMedGoogle ScholarCrossref
25.
Reidel  B , Radicioni  G , Clapp  PW ,  et al.  e-Cigarette use causes a unique innate immune response in the lung, involving increased neutrophilic activation and altered mucin secretion.   Am J Respir Crit Care Med. 2018;197(4):492-501. doi:10.1164/rccm.201708-1590OC PubMedGoogle ScholarCrossref
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